{"protocolSection":{"identificationModule":{"nctId":"NCT01316926","orgStudyIdInfo":{"id":"113939"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"Paxil CR Bioequivalence Study Brazil","officialTitle":"Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablet With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fasted Administration in Healthy Volunteers for Both Genders."},"statusModule":{"statusVerifiedDate":"2018-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-09-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2009-10-05","type":"ACTUAL"},"completionDateStruct":{"date":"2009-10-05","type":"ACTUAL"},"studyFirstSubmitDate":"2010-08-30","studyFirstSubmitQcDate":"2011-03-15","studyFirstPostDateStruct":{"date":"2011-03-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-03-24","resultsFirstSubmitQcDate":"2011-03-24","resultsFirstPostDateStruct":{"date":"2011-04-18","type":"ESTIMATED"},"lastUpdateSubmitDate":"2018-06-18","lastUpdatePostDateStruct":{"date":"2018-06-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).","detailedDescription":"Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fasted administration in healthy volunteers for both genders.\n\nThe study is open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).\n\nThe population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are not restrictions regarding the ethnic group.The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of concentration of drug in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each fasting period. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study."},"conditionsModule":{"conditions":["Depressive Disorder"],"keywords":["fast condition","Paroxetine reference/test","healthy volunteers","Bioequivalence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Paxil CR Reference","type":"ACTIVE_COMPARATOR","description":"Reference drug administration followed by test drug administration","interventionNames":["Drug: Test formulation","Drug: Reference formulation"]},{"label":"Paxil CR Test","type":"ACTIVE_COMPARATOR","description":"Test drug administration followed by Reference drug administration","interventionNames":["Drug: Test formulation","Drug: Reference formulation"]}],"interventions":[{"type":"DRUG","name":"Test formulation","description":"Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)","armGroupLabels":["Paxil CR Reference","Paxil CR Test"]},{"type":"DRUG","name":"Reference formulation","description":"Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)","armGroupLabels":["Paxil CR Reference","Paxil CR Test"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Area Under the Curve_steady-state","description":"The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC\\_steady-state (ss) is the area under the curve during the steady-state period. The AUC\\_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.","timeFrame":"Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)"},{"measure":"Cmin_steady-state","description":"Cmin\\_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin\\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.","timeFrame":"Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)"},{"measure":"Cmax_steady-state","description":"Cmax\\_steady-state (ss) is defined as the maximum or \"peak\" concentration of a drug observed after its administration, in steady-state. Cmax\\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.","timeFrame":"Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)"}]},"eligibilityModule":{"eligibilityCriteria":"EXCLUSION CRITERIA:\n\n* hypersensitivity to the study drug or to compounds chemically related;\n* history of serious adverse events;\n* concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;\n* History of liver, heart, gastrointestinal or renal illness;\n* ECG findings not recommended according to the investigator judgement;\n* The volunteer ingests more than 5 cups of coffee or tea a day.\n\nINCLUSION CRITERIA:\n\n* Man and woman (since they are not pregnant or breastfeeding);\n* age between 18 and 40 years;\n* non-smoker and not addict;\n* mass index between 18,5 and 27;\n* good health conditions or without significant illness, by judgement of a legally qualified professional;\n* sign the informed consent.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"40 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Belo Horizonte","state":"Minas Gerais","zip":"30110-014","country":"Brazil","geoPoint":{"lat":-19.92083,"lon":-43.93778}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Results for study 113939 can be found on the GSK Clinical Study Register.","url":"https://gsk-clinicalstudyregister.com/study/113939?search=study&study_ids=113939#rs"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All candidates are informed about the study, and all undergo clinical screening.","recruitmentDetails":"Recruitment is conducted in accordance with internal Standard Operating Procedures of the research center and with the consent of the participants (Term of Recruitment and Informed Consent Form).","groups":[{"id":"FG000","title":"Test Product in Period 1; Reference Product in Period 2","description":"Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2"},{"id":"FG001","title":"Reference Product in Period 1; Test Product in Period 2","description":"Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2"}],"periods":[{"title":"Period 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"One participant completed Period 1, but did not appear in Period 2","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Participants Receiving Both Test and Reference Product","description":"Participants receiving either test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in period 1 and test product in period 2"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"60"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.85","spread":"4.91"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"30"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"30"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Caucasian","categories":[{"measurements":[{"groupId":"BG000","value":"37"}]}]},{"title":"Black","categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]},{"title":"Mixed Race","categories":[{"measurements":[{"groupId":"BG000","value":"19"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Area Under the Curve_steady-state","description":"The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC\\_steady-state (ss) is the area under the curve during the steady-state period. The AUC\\_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.","populationDescription":"Participants who completed the study","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/h/ml","timeFrame":"Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)","groups":[{"id":"OG000","title":"Test Product","description":"Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods"},{"id":"OG001","title":"Reference Product","description":"Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"996.2436","spread":"546.1831"},{"groupId":"OG001","value":"1038.5812","spread":"550.8923"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.","paramType":"Ratio T formulation/R formulation","paramValue":"0.9204","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.8556","ciUpperLimit":"0.9900","estimateComment":"Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated."}]},{"type":"PRIMARY","title":"Cmin_steady-state","description":"Cmin\\_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin\\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.","populationDescription":"Participants who completed the study","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/ml","timeFrame":"Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)","groups":[{"id":"OG000","title":"Test Product","description":"Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods"},{"id":"OG001","title":"Reference Product","description":"Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.4410","spread":"15.7817"},{"groupId":"OG001","value":"27.9625","spread":"15.8840"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.","paramType":"Ratio T formulation/R formulation","paramValue":"0.9410","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.8460","ciUpperLimit":"1.0467","estimateComment":"Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated."}]},{"type":"PRIMARY","title":"Cmax_steady-state","description":"Cmax\\_steady-state (ss) is defined as the maximum or \"peak\" concentration of a drug observed after its administration, in steady-state. Cmax\\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.","populationDescription":"Participants who completed the study","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/ml","timeFrame":"Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)","groups":[{"id":"OG000","title":"Test Product","description":"Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods"},{"id":"OG001","title":"Reference Product","description":"Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61.0319","spread":"34.8551"},{"groupId":"OG001","value":"64.3281","spread":"35.7439"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.","paramType":"Ratio T formulation/R formulation","paramValue":"0.9333","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.8502","ciUpperLimit":"1.0246","estimateComment":"Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated."}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.","eventGroups":[{"id":"EG000","title":"Period 1","description":"Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1","seriousNumAffected":0,"seriousNumAtRisk":60,"otherNumAffected":42,"otherNumAtRisk":60},{"id":"EG001","title":"Period 2","description":"Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2","seriousNumAffected":0,"seriousNumAtRisk":59,"otherNumAffected":13,"otherNumAtRisk":59}],"otherEvents":[{"term":"Fever","organSystem":"General disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Cephalea","organSystem":"General disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":60},{"groupId":"EG001","numAffected":4,"numAtRisk":59}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Heartburn","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Stomach-ache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Xerostomia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Sore throat","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Dysphagia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Abdominal colic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Epigastric pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Dysuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Sleep disturbances","organSystem":"Nervous system disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Insomnia","organSystem":"Nervous system disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Rhinitis allergic","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Hyporexia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Lack of appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Mydriasis","organSystem":"Eye disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]},{"term":"Tonsillitis","organSystem":"Infections and infestations","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":2,"numAtRisk":59}]},{"term":"Menstrual pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Knee pain","organSystem":"Social circumstances","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59}]},{"term":"Fracture right upper limb","organSystem":"Social circumstances","sourceVocabulary":"ds Navigator","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The number of adverse events per intervention is not available in the final report."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial."},"pointOfContact":{"title":"GSK Response Center","organization":"GlaxoSmithKline","phone":"866-435-7343"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003866","term":"Depressive Disorder"}],"ancestors":[{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]}},"hasResults":true}